Jane Thompson, Ohio
I have no financial relationship with any group or company that may be affected by silicone breast implants.
After 16 years with my textured McGhan saline breast implants, I switched to Allergan’s new cohesive silicone gel breast implants last July. Almost immediately I began to feel quite ill. I had extreme fatigue, numbness and tingling, nausea, dizziness, heart palpitations, hair loss, depression, severe insomnia, ringing ears, weakness, stomach/headaches and anxiety.
Then around 3 months after getting the implants, other major symptoms appeared: chest pain, uncontrollable tremors, vertigo, widespread severe muscle/joint pain, symptoms similar to multiple sclerosis, difficultly swallowing, drooling, liver pain, loss of peripheral vision, symptoms of interstitial cystitis, severe skin tightness, face pain/lock jaw, vomiting, diarrhea, and dry throat/eyes. I was diagnosed with lymphadenopathy. I developed several ovarian cysts, stopped menses during this time, had tongue swelling, facial swelling, difficulty breathing, low white cell count, memory lapses and suicidal thoughts. I lost 20 lbs in 3 weeks. I became completely dependent on family and friends.
These were symptoms I had never had before, all of which developed in the short time I had Allergan cohesive gel breast implants. Prior to receiving these cohesive gel implants I had only seen my doctor twice a year for a refill of thyroid medication or the occasional minor illness or cold.
I had my implants surgically removed after 5 months, in December of 2010, and immediately the symptoms started to disappear. Ninety percent were gone immediately and the remainder of the symptoms disappeared over the next few weeks.
There are no words to fully describe the horrific experience these new cohesive gel implants caused me and my family. I received no warning about the possibility of the gels triggering my immune system and causing life-changing disease. I saw a total of five doctors during this time with my gel implants and they all believe the implants stimulated my immune system. Not one of those doctors doubts that I had a very strong immediate reaction to silicone gel.
My terrible autoimmune reaction was reported to Allergan, but in their records they falsely stated that my autoimmune symptoms occurred before my implants, not after. Their report states: “There is no complaint against the devices. The patient has a history of multiple medical concerns prior to implantation.” That is completely untrue. Prior to my gel implants I had a minor thyroid problem that was under control. After getting cohesive gel implants, I had very serious autoimmune symptoms that were completely devastating.
It wasn’t until after my gel implants were removed that I learned that Allergan excluded from their breast implant study any women with any kind of history of autoimmune symptoms, either personal history or family history. That information is not widely available, but is listed as a “precaution” on page 12 of the Allergan patient booklet, which states that safety has not been established for women with autoimmune diseases. This booklet is considered labeling that the FDA supposedly requires plastic surgeons to give to patients, but I never received a copy.
There should be a very obvious warning for women with any kind of personal or family history of autoimmune symptoms or diseases, with a black box around it. Instead, the FDA included the above vaguely worded precaution, which did not explain that women with autoimmune issues were intentionally excluded from studies because of concerns about how their health could be harmed. Since the FDA didn’t require that information, neither the companies nor the plastic surgeons are warning patients. And, earlier this summer, the FDA went on record as saying that there is no proven link to autoimmune diseases, without even mentioning that the implant companies excluded women with autoimmune symptoms or history from their breast implant studies. This is an outrageous situation. I was terribly harmed by my implants. A black box warning would have persuaded my doctor that I was at risk of health problems from breast implants because of my thyroid condition.
I was lucky that the link to my implants was so obvious, but what about the women who have mild or even moderate reactions? It might not be obvious to them or their doctors. Or, even for women who have an obvious reaction, remember that some of those women won’t be able to afford to have surgery to have their implants removed. You can get implants put in on an installment plan, but if you want them removed you need to pay before the surgery.
There need to be clear warnings about the dangers of silicone gel implants, so women can make an informed decision on whether or not to take that risk. And the research that you require on implants needs to focus on the kinds of autoimmune symptoms that women with implants are reporting.
Jane’s story was read at the FDA Advisory Committee Meeting on breast implants in August 2011.